Correlation Between Respiratory Variability of R-R Intervals and Systolic Pressure Variability
1 other identifier
observational
40
0 countries
N/A
Brief Summary
This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedAugust 30, 2017
August 1, 2017
1 year
August 28, 2017
August 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure
From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later
Study Arms (1)
Patient scheduled for surgery under general anesthesia
Interventions
Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O
Eligibility Criteria
Study patients
You may qualify if:
- Age 18-80
- Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring
You may not qualify if:
- Heart Rate other than sinus
- Cardiac Pacemaker Status
- Transplanted Heart
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Pediatric Anesthesia
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
November 1, 2017
Primary Completion
November 1, 2018
Study Completion
May 1, 2019
Last Updated
August 30, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share